Low-Cost Treatment Helps Prevent TB in People with HIV

Early results from CREATE studies support wider use of Isoniazid Preventive Therapy to prevent TB among people living with HIV;

BALTIMORE, November 11, 2010 - Early results from a group of clinical trials in Africa and South America
support wider use of a low-cost treatment to prevent the emergence of active
TB in people living with HIV/AIDS.

In a supplement published today in the journal AIDS, researchers
affiliated with the Consortium to Respond Effectively to the AIDS/TB Epidemic
(CREATE) note that isoniazid preventive therapy (IPT) -an antibiotic that is
part of the routine treatment for active TB disease and prevents the
emergence of active TB disease in HIV-infected people - produces minimal
associated health risks when monitored monthly by trained nurses. Globally,
TB is the leading cause of death for people infected with HIV, and effective
preventive therapies are essential to reduce TB-related morbidity and
mortality.

Isoniazid is a common antibiotic that has been used in TB treatment since
the late 1950s. While isoniazid is not recommended to be used alone for the
treatment of active TB disease, earlier studies have indicated that the risk
of developing drug resistance is minimal when IPT is administered to people
who are also latently infected with TB. IPT is administered as a nine-month
course of daily medication, and it effectively prevents active TB disease in
a high percentage of patients who complete a full course of treatment.

"This is exciting news for the global fight against TB and HIV," said Dr.
Richard Chaisson of Johns Hopkins University. "We have positive signs that
IPT provides a safe and effective way to prevent TB in people living with
HIV. The final results of the three trials that we are conducting in South
Africa, Zambia, and Brazil are not yet ready, but partial results from
studies conducted by Thibela TB in South Africa and THRio in Brazil suggest
that we are on the right path."

Dr. Chaisson serves as principal investigator of CREATE, a research
program funded by the Bill & Melinda Gates Foundation that is studying the
most effective ways to prevent, diagnose, and treat TB using currently
available medicines and technologies. CREATE was launched in 2004, and the
consortium expects to conclude a series of clinical trials in Brazil, South
Africa, and Zambia sometime in late 2011.

Both TB and HIV are prevalent among migrant workers who live and work in
the gold mining industry in South Africa, and several of the research
articles published in the AIDS supplement present data from a study of
community-wide IPT in South African gold mines. The research intervention was
conducted by the Aurum Institute of Johannesburg, in collaboration with the
London School of Hygiene & Tropical Medicine, between 2006 and 2010.

Among results released today, one of the articles found that mortality
was lower among individuals receiving IPT in combination with antiretroviral
therapy for HIV infection. These results support the routine use of IPT in
conjunction with ART.

The studies also determined that people who undergo IPT experience few
adverse events. Of the 24,221 participants in the clinical trial, only 130
experienced important side effects related to treatment. Serious adverse
events, like liver toxicity, were rare, and the study found that clinical
criteria can be used to screen patients for serious toxicity risks and safely
monitor patients while they are on IPT.

Another paper established that chest radiography, where available, can be
a useful adjunct to symptom screening in ruling out active TB. The
identification and exclusion of active TB cases is critical to ensuring the
long-term effectiveness of IPT because active TB must be treated with a
combination of antibiotics to prevent the development of drug-resistant TB
strains.

While patient uptake to IPT was surprisingly high in the Thibela TB
study, one of the studies found that healthcare workers serve as the primary
barrier to widespread adoption of IPT for HIV-infected patients in the local
clinic setting. Lack of experience with IPT among physicians must be
addressed with efforts to raise awareness of the treatment by local
healthcare leaders. New South African government national guidelines on the
use of IPT for HIV-infected individuals have been recently released in the
hope that more healthcare providers will adopt the use of IPT for people
living with HIV.

In a CREATE study conducted among 29 public health clinics in Rio de
Janeiro Brazil, over 5,000 HIV-infected patients have had tuberculin skin
tests placed; 94% have been read and 18% were positive. Eighty-three percent
of those with positive skin tests have completed therapy to date and < 2%
have had minor adverse effects. This study demonstrates that IPT can be
incorporated successfully into existing public health clinics.

About CREATE (Consortium to Respond Effectively to the AIDS/TB Epidemic)

Representing researchers, clinicians, policy makers, AIDS/TB control
programs, and the community at large, the CREATE Consortium is implementing
research studies to assess the impact of bold, new public health paradigms
for controlling the AIDS/TB epidemic.

Led by Dr. Richard Chaisson of the Johns Hopkins Center for Tuberculosis
Research, CREATE hopes to transform global policies for TB/HIV through
evidence-based advocacy.

We invite you to visit the studies in our website (
tbhiv-create.org) to find out how they are progressing and what impact
they will have in the future of TB/HIV policies and advocacy efforts.

About the Aurum Institute

The Aurum Institute is internationally-recognised, non-profit, specialist
research and health systems management organisation, with a 12 year history
of leading the response, treatment, and research efforts against TB and
HIV/AIDS in South Africa.

Aurum's mission is to improve the health of people and communities
through innovative, integrated approaches to the TB and HIV epidemics,
including:

    1) Conducting transformational research that seeks to inform
       international and national prevention, treatment and care policy and
       practice in TB and HIV.
    2) Designing, testing and implementing health systems and
       approaches and supporting the State in bringing care and treatment to
       people living with HIV/AIDS and tuberculosis, and their communities.
    3) Operating at the highest levels of governance and efficiency to
       ensure that partner and donor funding reaches maximum potential and
       intended outcomes.

Aurum has an international reputation for its work in the fields of
tuberculosis and HIV/AIDS and is the recipient of research and other grants
from South African and international agencies and institutions for this work.
Aurum is acknowledged by funders, donors, the private sector, other
non-governmental organisations and communities as a partner highly capable of
conducting ethical research and delivering reliable results. Aurum adds value
by supplying the context, expertise and experience for our partners to make
better-informed health related management and treatment decisions.

Aurum is based in Johannesburg, South Africa with operations throughout
the country and collaborations across the globe. For more information, please
visit www.auruminstitute.org.

Claudia Costabile, ccostab1 at jhmi.edu, +1-410-614-6217